Description
DUTIES AND RESPONSIBILITIES:- Represent Q.A. Engineering during New Product Development and Design Review. Actively participate in all aspects of Design Control. Primary emphasis in software and electrical device characteristics.
- Tracing and defining requirements throughout their lifecycle.
- Implements qualification tests procedures to ensure that new products will meet specification requirements.
- Analyzes test results, writes qualification test reports, and presents such reports to Review Board for approval.
- Reviews and analyzes Research and Development's (R&D's) design and verification tests to determine that Company standards are met. Contributes to R&D concept anddesign review meetings.
- Performs Failure Modes and Effect Criticality Analysis (FMECA) with project team members.
- Contributes to qualification testing and activities to ensure that trained manpower, procedures and equipment are in place to complete necessary testing.
- Evaluate and recommend QA sampling plans based on desired confidence limits, process capabilities, and manufacturing/inspection methods and equipment.
- Oversees compliance with testing procedure and that data collection and recording are also in compliance.
- Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments.
- Bachelor's degree required preferably in an Engineering or Science discipline. At least three years experience (five years preferred) in a product development or Design Assurance position in a Medical Device or other highly regulated industry.
- Knowledge of program management/software development lifecycle methodologies such as scrum or agile. Use and application of testing equipment, statistical methods and control plans.